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Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343
Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343
Background: Rheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA.
Methods/design: 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel.
Discussion: This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care.
Trial registration: Current Controlled Trials ISRCTN89936343
Keywords: Randomised controlled trial, Rheumatoid arthritis, Exercise, Hand, Rehabilitation
Sarah Trial Team, The
dfbee91f-71a3-4ce2-a00c-54f6c978d250
Adams, Jo
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Bridle, Chris
f38e2a99-82fe-4172-b493-91d081f364db
Dosanjh, Sukhdeep
3161ed3c-4d89-48a4-9447-7561b2d4398c
Heine, Peter
53141b60-a5d8-4280-8905-3737689f9a22
Lamb, Sarah
ab6c6075-2b9e-4341-8343-491290a3d33e
Lord, Joanne
fd3b2bf0-9403-466a-8184-9303bdc80a9a
McConkey, Christopher
d78e637f-895c-4986-ad37-fc4bca23cece
Nicols, Vivien
2cdb268c-98bf-46a2-b550-151c8740d539
Toye, Francine
c3383ea4-b87b-4d50-aecb-d35f2e3b5620
Underwood, Martin
239a8609-e7b5-4acb-aaf9-9e7f717f0d62
Williams, Mark
1d702937-6b71-4078-9027-281ad88a6d10
Williamson, Esther
8adb517c-ddbc-4474-ab04-2e6108d856a5
Sarah Trial Team, The
dfbee91f-71a3-4ce2-a00c-54f6c978d250
Adams, Jo
6e38b8bb-9467-4585-86e4-14062b02bcba
Bridle, Chris
f38e2a99-82fe-4172-b493-91d081f364db
Dosanjh, Sukhdeep
3161ed3c-4d89-48a4-9447-7561b2d4398c
Heine, Peter
53141b60-a5d8-4280-8905-3737689f9a22
Lamb, Sarah
ab6c6075-2b9e-4341-8343-491290a3d33e
Lord, Joanne
fd3b2bf0-9403-466a-8184-9303bdc80a9a
McConkey, Christopher
d78e637f-895c-4986-ad37-fc4bca23cece
Nicols, Vivien
2cdb268c-98bf-46a2-b550-151c8740d539
Toye, Francine
c3383ea4-b87b-4d50-aecb-d35f2e3b5620
Underwood, Martin
239a8609-e7b5-4acb-aaf9-9e7f717f0d62
Williams, Mark
1d702937-6b71-4078-9027-281ad88a6d10
Williamson, Esther
8adb517c-ddbc-4474-ab04-2e6108d856a5

Sarah Trial Team, The, Adams, Jo, Bridle, Chris, Dosanjh, Sukhdeep, Heine, Peter, Lamb, Sarah, Lord, Joanne, McConkey, Christopher, Nicols, Vivien, Toye, Francine, Underwood, Martin, Williams, Mark and Williamson, Esther (2012) Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343. BMC Musculoskeletal Disorders, 13. (doi:10.1186/1471-2474-13-230).

Record type: Article

Abstract

Background: Rheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA.
Methods/design: 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel.
Discussion: This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care.
Trial registration: Current Controlled Trials ISRCTN89936343
Keywords: Randomised controlled trial, Rheumatoid arthritis, Exercise, Hand, Rehabilitation

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Published date: November 2012
Organisations: Physical & Rehabilitation Health

Identifiers

Local EPrints ID: 347423
URI: https://eprints.soton.ac.uk/id/eprint/347423
PURE UUID: 88d5ce2f-345c-4bc6-9527-22f709e775e8
ORCID for Jo Adams: ORCID iD orcid.org/0000-0003-1765-7060
ORCID for Joanne Lord: ORCID iD orcid.org/0000-0003-1086-1624

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Date deposited: 28 Jan 2013 14:54
Last modified: 18 May 2019 00:38

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Contributors

Author: The Sarah Trial Team
Author: Jo Adams ORCID iD
Author: Chris Bridle
Author: Sukhdeep Dosanjh
Author: Peter Heine
Author: Sarah Lamb
Author: Joanne Lord ORCID iD
Author: Christopher McConkey
Author: Vivien Nicols
Author: Francine Toye
Author: Martin Underwood
Author: Mark Williams
Author: Esther Williamson

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